Toxicology and carcinogenesis studies of black cohosh root extract (CASRN 84776-26-1) administered by gavage to Sprague Dawley (Hsd:Sprague Dawley SD) rats and female B6C3F1/N mice.

Black cohosh (Actaea racemose L.) is widely used as a botanical dietary supplement to alleviate female gynecological symptoms, such as premenstrual syndrome and changes associated with menopause, and to stimulate labor. Despite its popularity, limited data are available on the long-term safety of black cohosh products. To address this knowledge gap, 2-year National Toxicology Program (NTP) carcinogenicity studies were conducted in Sprague Dawley (Hsd:Sprague Dawley SD) rats and B6C3F1/N mice. To emulate a potential human exposure scenario in which a woman might use black cohosh throughout pregnancy and lactation, perinatal exposure was included for the rat study. (Abstract Abridged).